Ignite Creation Date:
2025-12-24 @ 7:57 PM
Ignite Modification Date:
2026-01-25 @ 5:13 AM
Study NCT ID:
NCT03913104
Status:
COMPLETED
Last Update Posted:
2024-08-14
First Post:
2019-04-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mail Order Mifepristone Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-07-17', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'D015735', 'term': 'Mifepristone'}], 'ancestors': [{'id': 'D004963', 'term': 'Estrenes'}, {'id': 'D004962', 'term': 'Estranes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'natalie.morris@ucsf.edu', 'phone': '(415) 353-4724', 'title': 'Natalie Morris', 'organization': 'University of California, San Francisco'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'Lack of randomization may limit generalizability. Clinical sites that agreed to participate had at least 1 motivated clinician and a supportive administrative environment and were located in states with relatively few abortion restrictions. Study participants were open to mail-order dispensing, but this option may not be acceptable/feasible for all patients. The study was not powered to precisely estimate safety outcomes. Satisfaction may be overestimated due to social desirability bias.'}}, 'adverseEventsModule': {'timeFrame': 'Follow-up data were collected among participants up to six weeks after initial medication abortion visit.', 'description': 'Adverse events were defined as any unscheduled visits, including emergency department visits, for symptoms possibly related to the medication abortion. Serious adverse events were defined as death, hospitalization, blood transfusion, or surgery.', 'eventGroups': [{'id': 'EG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.', 'otherNumAtRisk': 510, 'deathsNumAtRisk': 510, 'otherNumAffected': 21, 'seriousNumAtRisk': 510, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 9, 'numAffected': 9}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Nausea/vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Incomplete abortion', 'notes': 'Less than 5% of medication abortion cases lead to incomplete abortions; in these cases, the patients visited the emergency department with symptoms and received aspiration procedures to complete their abortions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Vaginitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Shortness of breath', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}], 'seriousEvents': [{'term': 'Hemorrhage requiring blood transfusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}, {'term': 'Hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 510, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'FDA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'categories': [{'title': 'Very satisfied', 'measurements': [{'value': '452', 'groupId': 'OG000'}]}, {'title': 'Somewhat satisfied', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}, {'title': 'Neither satisfied nor dissatisfied', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Somewhat dissatisfied', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Very dissatisfied', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 14 following initial medication abortion visit', 'description': 'Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'PRIMARY', 'title': 'Acceptability: Would Use Mail-Order Dispensing Again', 'denoms': [{'units': 'Participants', 'counts': [{'value': '473', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '477', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '431', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '20', 'groupId': 'OG000'}]}, {'title': 'Not sure', 'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 14 following initial medication abortion visit', 'description': 'Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'SECONDARY', 'title': 'Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'title': 'Medications delivered by Day 2', 'categories': [{'measurements': [{'value': '381', 'groupId': 'OG000'}]}]}, {'title': 'Medications delivered by Day 3', 'categories': [{'measurements': [{'value': '436', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 3 following initial medication abortion visit', 'description': 'Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'SECONDARY', 'title': 'Feasibility: Confidentiality Maintained When Receiving Medications by Mail', 'denoms': [{'units': 'Participants', 'counts': [{'value': '491', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '495', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'categories': [{'title': 'Yes, confidentiality was maintained', 'measurements': [{'value': '486', 'groupId': 'OG000'}]}, {'title': 'No, confidentiality was compromised', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Day 3 following initial medication abortion visit', 'description': 'Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'SECONDARY', 'title': 'Clinical Effectiveness of Mail-Order Medication Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'categories': [{'title': 'Abortion complete with medications only', 'measurements': [{'value': '499', 'groupId': 'OG000'}]}, {'title': 'Incomplete abortion', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Ongoing pregnancy', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 6 weeks after initial medication abortion visit.', 'description': 'Percentage of participants who experienced a complete medication abortion, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'SECONDARY', 'title': 'Clinical Safety of Mail-Order Medication Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'OG000'}]}, {'units': 'Number of abortions', 'counts': [{'value': '510', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'title': 'Adverse Event Related to Medication Abortion', 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Serious Adverse Event Related to Medication Abortion', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Adverse Event Related to Mail-Order Dispensing', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 6 weeks after initial medication abortion visit.', 'description': 'Percentage of participants who experience adverse events related to the abortion, by abortion instance.', 'unitOfMeasure': 'Number of abortions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Number of abortions', 'denomUnitsSelected': 'Number of abortions'}, {'type': 'SECONDARY', 'title': 'Provider Acceptability of Mail-Order Dispensing of Medication Abortion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Staff and Clinicians Involved in Mail-order Dispensing at Study Sites', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 months after data collection completed.', 'description': 'Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Clinicians and staff involved in implementing a mail-order dispensing model for medication abortion were invited to complete qualitative interviews to share their experiences with non-in-person dispensing of mifepristone. These clinicians and staff were not officially enrolled as participants in the study, but rather contributed perspectives as clinic employees on the feasibility and acceptability of such a model.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '540', 'numSubjects': '536'}]}, {'type': "Patient's Clinical Outcome Information Obtained", 'achievements': [{'groupId': 'FG000', 'numUnits': '510', 'numSubjects': '506'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '510', 'numSubjects': '506'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '30', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'Did Not Take Mifepristone or Misoprostol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}], 'typeUnitsAnalyzed': 'Number of abortions', 'preAssignmentDetails': '536 patients were consented and enrolled as part of this study. Four participants enrolled twice and were analyzed based on their abortion instance, leading to 540 abortions analyzed as part of this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)\n\nMifepristone: Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000', 'lowerLimit': '23', 'upperLimit': '31'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': 'Age, Categorical', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'title': '15-19 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': '20-24 years', 'measurements': [{'value': '144', 'groupId': 'BG000'}]}, {'title': '25-29 years', 'measurements': [{'value': '161', 'groupId': 'BG000'}]}, {'title': 'Greater than or equal to 30 years', 'measurements': [{'value': '171', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female'}, {'title': 'Male'}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Sex/Gender data not collected'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and ethnicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Black', 'measurements': [{'value': '194', 'groupId': 'BG000'}]}, {'title': 'Hispanic', 'measurements': [{'value': '88', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '141', 'groupId': 'BG000'}]}, {'title': 'Multiracial/other race', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '506', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Educational level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'title': 'High school or less', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}, {'title': 'Some college or professional school', 'measurements': [{'value': '206', 'groupId': 'BG000'}]}, {'title': 'College or advanced degree', 'measurements': [{'value': '112', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Parity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Nulliparous', 'measurements': [{'value': '189', 'groupId': 'BG000'}]}, {'title': 'Parous', 'measurements': [{'value': '317', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Prior abortion experience', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '506', 'groupId': 'BG000'}]}], 'categories': [{'title': 'None', 'measurements': [{'value': '249', 'groupId': 'BG000'}]}, {'title': 'Medication abortion', 'measurements': [{'value': '149', 'groupId': 'BG000'}]}, {'title': 'Procedural abortion only', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Missing data', 'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-10-25', 'size': 646502, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-18T19:13', 'hasProtocol': True}, {'date': '2021-11-12', 'size': 241341, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-06-18T19:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Prospective Cohort'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 536}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-23', 'studyFirstSubmitDate': '2019-04-03', 'resultsFirstSubmitDate': '2024-06-24', 'studyFirstSubmitQcDate': '2019-04-10', 'lastUpdatePostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-07-23', 'studyFirstPostDateStruct': {'date': '2019-04-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability: Satisfaction With Mail-Order Dispensing of Medication Abortion', 'timeFrame': 'Day 14 following initial medication abortion visit', 'description': 'Percentage of participants reporting whether they were satisfied with receiving the medications by mail, by abortion instance.'}, {'measure': 'Acceptability: Would Use Mail-Order Dispensing Again', 'timeFrame': 'Day 14 following initial medication abortion visit', 'description': 'Percentage of participants reporting they would prefer to receive medications by mail for future medication abortion, by abortion instance.'}], 'secondaryOutcomes': [{'measure': 'Feasibility: Proportion of Patients Who Receive Medications by Day 2 and Day 3', 'timeFrame': 'Day 3 following initial medication abortion visit', 'description': 'Percentage of participants who received the medications by mail-order pharmacy by Day 2 and Day 3, by abortion instance.'}, {'measure': 'Feasibility: Confidentiality Maintained When Receiving Medications by Mail', 'timeFrame': 'Day 3 following initial medication abortion visit', 'description': 'Percentage of participants who reported that confidentiality was maintained when they received the medications by mail-order pharmacy, by abortion instance.'}, {'measure': 'Clinical Effectiveness of Mail-Order Medication Abortion', 'timeFrame': 'Up to 6 weeks after initial medication abortion visit.', 'description': 'Percentage of participants who experienced a complete medication abortion, by abortion instance.'}, {'measure': 'Clinical Safety of Mail-Order Medication Abortion', 'timeFrame': 'Up to 6 weeks after initial medication abortion visit.', 'description': 'Percentage of participants who experience adverse events related to the abortion, by abortion instance.'}, {'measure': 'Provider Acceptability of Mail-Order Dispensing of Medication Abortion', 'timeFrame': 'Up to 3 months after data collection completed.', 'description': 'Provider acceptability will be assessed qualitatively through open-ended interviews with providers and staff involved in the study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Abortion Early', 'Pregnancy Related']}, 'referencesModule': {'references': [{'pmid': '38956609', 'type': 'DERIVED', 'citation': 'Raifman S, Gurazada T, Beaman J, Biggs MA, Schwarz EB, Gold M, Grossman D. Primary care and abortion provider perspectives on mail-order medication abortion: a qualitative study. BMC Womens Health. 2024 Jul 3;24(1):382. doi: 10.1186/s12905-024-03202-z.'}, {'pmid': '34555420', 'type': 'DERIVED', 'citation': 'Grossman D, Raifman S, Morris N, Arena A, Bachrach L, Beaman J, Biggs MA, Hannum C, Ho S, Schwarz EB, Gold M. Mail-order pharmacy dispensing of mifepristone for medication abortion after in-person clinical assessment. Contraception. 2022 Mar;107:36-41. doi: 10.1016/j.contraception.2021.09.008. Epub 2021 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the feasibility, acceptability, and effectiveness of dispensing mifepristone via a mail-order pharmacy. The investigators will recruit patients at up to 10 primary care and internal medicines sites not currently providing abortion services around the country, as well as abortion clinic sites. Patients will go through routine in clinic visits to determine eligibility and then will receive the medications in the mail at their preferred address. The investigators will survey patients 3 and 14 days after the initial clinic visit and interview providers at the end of the study.', 'detailedDescription': 'This is a prospective cohort study of patients obtaining medication abortion via mifepristone dispensed from an online mail order pharmacy. After an initial pilot test with 25 patients, the investigators will identify 10 clinics to participate in the study. The study team will train primary care providers not currently providing abortion to provide medication abortion with the medications dispensed via mail order pharmacy. The investigators aim to recruit up to 650 patients for this study across all the sites. Patients will come in for an initial consult visit at the study site and then receive their medications at a preferred address within 3 days of the initial visit. Study participants will fill out surveys about their experience and feedback about the acceptability of the process; this will occur at 3 and 14 days after the initial recruitment visit. The investigators will also collect clinic data from patients and clinic sites to track clinical outcomes. And the investigators will interview providers at the end of the study to better understand their experiences prescribing mifepristone via mail-order.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women seeking medication abortion through 63 days gestation\n* Eligible for MifeprexⓇ at a study site\n* English or Spanish speaking\n* Willing and able to participate in the study, including willing and able to receive medications at home or other preferred address within 3 days of initial medication abortion visit\n\nExclusion Criteria:\n\n* Not pregnant\n* Not seeking medication abortion\n* under the age of 15\n* Over 63 days gestation\n* Contraindicated for medication abortion'}, 'identificationModule': {'nctId': 'NCT03913104', 'briefTitle': 'Mail Order Mifepristone Study', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Feasibility and Acceptability of Dispensing Mifepristone Via Mail Order Pharmacy', 'orgStudyIdInfo': {'id': '18-26819'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medication Abortion Patients', 'description': 'Oral Mifepristone 200 mg, followed by misoprostol 800 mcg administered buccally (at 24-48 hours following mifepristone)', 'interventionNames': ['Drug: Mifepristone']}], 'interventions': [{'name': 'Mifepristone', 'type': 'DRUG', 'description': 'Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.', 'armGroupLabels': ['Medication Abortion Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94602', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'Highland Hospital', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Oakland", 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Planned Parenthood Rocky Mountains', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '19899', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Care Health System', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '30324', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Atlanta Comprehensive Wellness Clinic', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '10461', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Albert Einstein College of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '13850', 'city': 'Vestal', 'state': 'New York', 'country': 'United States', 'facility': "Southern Tier Women's Health Services", 'geoPoint': {'lat': 42.08507, 'lon': -76.05381}}, {'zip': '19013', 'city': 'Chester', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Delaware County Women's Center", 'geoPoint': {'lat': 39.84753, 'lon': -75.35785}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny Reproductive Health Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02860', 'city': 'Pawtucket', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Brown Family Medicine', 'geoPoint': {'lat': 41.87871, 'lon': -71.38256}}, {'zip': '02905', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Lifespan', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Daniel Grossman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Daniel Grossman, MD', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor and Director of ANSIRH', 'investigatorFullName': 'Daniel Grossman, MD', 'investigatorAffiliation': 'University of California, San Francisco'}}}}